mitizodone phosphate (HEC113995 PA) / Sunshine Lake Pharma - LARVOL DELTA

The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder (clinicaltrials.gov) - P2/3 | N=600 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: May 2024 ➔ Nov 2027 | Trial primary completion date: Apr 2024 ➔ Jul 2027

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A phase I study to evaluate the safety, tolerability, and pharmacokinetics of HEC113995PA·H2O, a novel dual-acting serotonergic antidepressant, in healthy subjects. (PubMed, Front Pharmacol) - "HEC113995PA·H2O was safe and generally well-tolerated in healthy subjects. Based on the pharmacokinetic and safety data mentioned above, we expect that postprandial administration will favorably increase drug concentrations in the body and reduce gastrointestinal adverse events."

Journal • P1 data • PK/PD data • Gastrointestinal Disorder

The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder (clinicaltrials.gov) - P2/3; N=600; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Initiation date: Aug 2021 ➔ Nov 2021

Clinical • Trial initiation date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder (clinicaltrials.gov) - P2/3; N=600; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

New P2/3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

The Study of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O,in Healthy Subjects (clinicaltrials.gov) - P1; N=69; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion

the Safety, Tolerability, and Pharmacokinetics Study of HEC113995 (clinicaltrials.gov) - P1; N=58; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Dec 2020 ➔ Aug 2020

Clinical • Trial completion • Trial completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

the Safety, Tolerability, and Pharmacokinetics Study of HEC113995 (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC113995 PA•H2O Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=69; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry